The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment
|ClinicalTrials.gov Identifier: NCT01596205|
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : May 10, 2012
Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.
The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.
The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Cognitive Decline||Behavioral: Robot assisted cognitive training Behavioral: Conventional cognitive training group||Not Applicable|
Primary outcome The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.
Secondary outcomes Change in the brain functional network from the baseline to the postintervention assessment was also assessed as a secondary outcome ascertained by the analysis of resting state fMRI, which has been used to show correlated spontaneous activity within cortical and subcortical regions that are functionally related.
Further secondary outcomes were changes between the baseline and the post-intervention assessment on cognitive function measured by validated neuropsychological tests such as SNSB and CANTAB on participants' depressive and anxiety symptoms scored by Geriatric Depression Scale and Geriatric Anxiety Inventory respectively, on self reported memory problems measured by Korean Dementia Screenng Questionnaire, Multifactorial Memory Questionnaire and Prospective and Retrospective Memory Questionnaire, on functions of daily living acitivity measured by Bayer ADL, on quality of life measuared by WHOQOL-bref.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Robot intervention
Participants were given baseline assessments and randomly assigned into 3 groups; 24 with robot assisted cognitive training group (Robot intervention group), 24 with experienced behavioral therapist group (Conventional intervention group), and 37 without cognitive training (Control group).It was explained that there was a waiting list, therefore, participants in control group had an opportunity to participate in cognitive training program after a delay of 12 weeks for the intervention.
Behavioral: Robot assisted cognitive training
We developed total 17 software programs for cognitive training with robot which were intended to develop for improvement of following cognitive function;5 programs for memory, 2 for language , 1 for reasoning, 3 for working memory or speed of processing, 2 for calculation and 4 for visuospatial function.
Active Comparator: Conventional intervention
conventional cognitive training group - pen and pencil with experienced behavioral therapists
Behavioral: Conventional cognitive training group
Experienced behavioral therapists who had been clinical neuropsychologists for 2 years instructed the participants in cognitive training. Thearpists were familiarized with manuals for cognitive training before study inception, and were instructed to adhere to the manual but were allowed to distribute time flexibly among the programs in the same cognitive domain.
In all sessions of conventional intervention group, the behavioral therapists showed several questions or instructions on the screen and then the participants answered to the questions with verbal or written words using paper and pencil.
|No Intervention: Control group|
- the change in cortical thickness between the baseline and the post-intervention assessment. [ Time Frame: between the baseline and the post-intervention assessment (12 week training) ]The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596205
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Duk L. Na, MD,PhD||Samsung Medical Center|